CN102046239A - A method and system for dynamic recalibration of tens stimulation points to compensate for changing electrode conditions with fail-safe and auto-recovery functionality - Google Patents
A method and system for dynamic recalibration of tens stimulation points to compensate for changing electrode conditions with fail-safe and auto-recovery functionality Download PDFInfo
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- CN102046239A CN102046239A CN2009801177805A CN200980117780A CN102046239A CN 102046239 A CN102046239 A CN 102046239A CN 2009801177805 A CN2009801177805 A CN 2009801177805A CN 200980117780 A CN200980117780 A CN 200980117780A CN 102046239 A CN102046239 A CN 102046239A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
Abstract
The invention relates to a device (10) for applying transcutaneous electrical nerve stimulation via an electrode (22), and to a method of transcutaneous electrical nerve stimulation. The device comprises the electrode being arranged for detecting a change of a skin impedance and being configured for switching from a stimulation mode of operation (30) for stimulating the nerve into a recalibration mode of operation (32) upon detection of the changed skin impedance. In an embodiment, the device comprises a plurality of electrodes being configured for detecting the change of the skin impedance and being configured for adjusting an electrical current flowing through the skin via the plurality of electrodes.
Description
Technical field
The present invention relates to be used for the equipment and the method for transcutaneous electric nerve stimulation (TENS).
Background technology
Transcutaneous electric nerve stimulation (TENS; Also referring to Fig. 1) be the common type of electroanalgesia (electric pain relief).Exist TENS to be used for the hundreds of clinical report of a lot of type conditions (such as lower back portion pain, muscular fasciae and arthralgia, sympathetic nerve conduction pain, urinary incontinence, neuropathic pain, Encelialgia and postoperative pain).TENS is that the surface (=percutaneous) at skin applies electricity irritation, is mainly used in pain relief.Outer surface electrode via the electrical waveform of using some types that characterized by frequency, pulse period and amplitude applies TENS.Apply the lenitive technology of electric current and establish for a long time, but after the scientific basic of foundation about pain relief mechanism, after nineteen sixty-five, win a large amount of scientific interest.TENS is no medicine, non-diffusion and unlikely addiction.It is almost without any taboo.
The shortcoming of known TENS equipment and method be they for example do not handle because move, the fluctuation of skin electric conductivity that dampness accumulation or transformation temperature cause.In known system, this may cause following result:
-between skin and electrode, have in the very bad situation about being connected, stimulation may cause voltage obviously rise=＞may be undesirable painful experience.
-in the situation of resistance level frequent variations inconvenience or the trouble anti-fault mechanism.If equipment enters anti-malfunction, then the user needs restarting equipment continually.This is that the user is disagreeableness.
The stimulation point of-selection early may no longer be correct point.
Summary of the invention
Except that other, the objective of the invention is to create the TENS equipment that uses in the environment that a kind of electrical conductivity that is suitable between skin and electrode fluctuates in time.
For this reason, the invention provides described equipment of claim 1 and the described method of claim 14.
A first aspect of the present invention comprises a kind of equipment that is used for applying via electrode transcutaneous electric nerve stimulation, and this arrangement of electrodes becomes to be used for the variation of detection of skin impedance and is disposed for switching to the recalibration operator scheme from neuroactive stimulation applications pattern when detecting the Skin Resistance of variation.
The effect of present device is that when detecting the variation of Skin Resistance, equipment changes to the recalibration operator scheme with its operator scheme from stimulating operator scheme.During recalibrating operator scheme, the position of electrode or provide the selected electrode of nerve stimulation signal to change to skin from a plurality of electrodes.Therefore, equipment for example can be measured impedance during the recalibration pattern, and for example as long as Skin Resistance is lower than predetermined threshold once more and just switches to the stimulation applications pattern.Therefore, during the conductivity variations between skin and the electrode, make it possible to comparatively fast turn back to the stimulation applications pattern, make it possible to only to interrupt pain when therefore the conductivity variations between skin and electrode is registered shortly and suppress to the switching of recalibrating operator scheme.Therefore, the comfort of equipment is obviously improved.
That known TENS equipment has is so-called " anti-fault " mechanism, arrestment when its contact between electrode and skin may be broken.If this interruption takes place, the user generally must restarting equipment, this trouble and make people's unhappiness of becoming.And " anti-fault " mechanism not counter electrode is made a response to the displacement of another location from a position on the skin.When not breaking with the contacting of skin when dislocation of electrode, electrode may be in the suboptimum position, and this may reduce effective pain relief and even may cause pain.
In equipment of the present invention, enter the recalibration pattern during variation in detecting Skin Resistance.This variation of Skin Resistance may come from electrode to the displacement of more not optimizing the position or may be owing to move the electrode cause and the bad contact between the skin.In the recalibration pattern, the signal that electrode applies to skin is general lower and for example be used for the impedance of measurement electrode or a plurality of electrodes.When applying electrode again or when making that electrode turns back to optimum position, detected and equipment can directly turn back to the stimulation applications pattern that applies pain relief again to returning of original value in impedance.
In an embodiment of equipment, equipment comprises a plurality of electrodes, and these a plurality of electrodes are configured to the variation of detection of skin impedance and are configured to regulate via the endermic electric current of a plurality of electrode stream.Use electrod-array can realize being used for first electrode more simply the switching of stimulus signal to second electrode that will be used for stimulus signal.
In an embodiment of equipment, the Skin Resistance of variation causes the fault in the functions of the equipments.
In an embodiment of equipment, equipment is configured to provide transcutaneous electric nerve stimulation via one simultaneously with top electrode, and wherein equipment is configured to change the voltage of each electrode that is used to apply transcutaneous electric nerve stimulation.Use the benefit of a plurality of electrodes to be simultaneously, it can reduce skin and a plurality of impedance between electrodes, and can increase the area that receives stimulation.Another advantageous embodiment comprises electrod-array, and wherein electrode has less size.1 * 1 millimeter or littler size make it possible to select a lot of electrodes, the tighter zone that has on the low-impedance relatively skin that thickly covers of these electrodes.This can relatively easily finish via the known semiconductor manufacturing technology that can make the submillimeter electrode.Even more preferably, the size of electrode can be 0.5 * 0.5 millimeter or littler, and this can even more closely cover the zone that has on the low-impedance relatively skin.
When the change in voltage of each electrode that is used to apply transcutaneous electric nerve stimulation, be used to provide the signal of transcutaneous electric nerve stimulation can be at each electrode regulating, thereby for example because that local impedance changes is former thereby optimize electrode.Therefore, the electric current that is provided to skin can be distributed to all electrodes that are used to provide transcutaneous electric nerve stimulation equably.
In an embodiment of equipment, equipment is configured to convert in response to the change in voltage that the Skin Resistance that changes will be used to apply transcutaneous electric nerve stimulation the variation of the electrode number that is used to provide transcutaneous electric nerve stimulation.Be used for providing the required voltage of transcutaneous electric nerve stimulation to change the variation (thereby variation of resistance) that is changed into the electrode number that is used for chafe.Present embodiment provides more controls of stimulated zone for the doctor, and especially it allows the very stimulation of zonule, this means that voltage is near its maximum.Therefore, if the user wishes to increase electric current, can no longer increase voltage, thereby can increase electrode number, the electric current of increase is fed to skin via these electrodes.
In an embodiment of equipment, the stimulation applications pattern comprises stimulation voltage and wherein recalibrates operator scheme and comprise measuring voltage that this measuring voltage is lower than this stimulation voltage.For the impedance of measurement electrode position, typically need not too strong signal.In order to reduce to recalibrate the signal during the operator scheme, the gross energy of devices consume is reduced.And, the convenience that reduces to have improved patient of signal intensity during recalibrating operator scheme.When the contact between electrode and the skin was not the best, big voltage may occur, and makes patient have the experience of pain.Can avoid this type of incident to take place by during recalibrating operator scheme, reducing signal intensity.
In an embodiment of equipment, equipment is configured to apply the required voltage of transcutaneous electric nerve stimulation and/or come from substantial constant voltage via monitoring with the substantial constant electric current via monitoring apply the resulting electric current of transcutaneous electric nerve stimulation and/or come the Skin Resistance of change detected via the resistance of measurement electrode.The monitoring stimulation voltage makes it possible to detect the variation in the impedance, applies transcutaneous electric nerve stimulation simultaneously.Therefore, the detection of Skin Resistance variation does not need to interrupt applying transcutaneous electric nerve stimulation.The electrode that is not used in nerve stimulation can be measured via resistance measurement method, and this generally needs less power.
In an embodiment of the equipment that comprises a plurality of electrodes, equipment is disposed for one by one or the resistance of measurement electrode in groups.This group for example can be originally to have had more low-resistance electrode collection, therefore can derive the new electrode that is used to provide the transcutaneous electric nerve stimulation signal from a plurality of electrodes relatively apace.
In an embodiment of the equipment that comprises a plurality of electrodes, this equipment is disposed for the variation of detection of skin impedance during the stimulation applications pattern, be used to apply the resistance of the voltage measurement of transcutaneous electric nerve stimulation via monitoring from the stimulating electrode of these a plurality of electrodes, this equipment (10 wherein, 12,14) be configured to detect resistance from the non-stimulating electrode (22) of these a plurality of electrodes (18) via the measuring voltage of measurement electrode (22) resistance, this stimulating electrode (22) is disposed for applying transcutaneous electric nerve stimulation, and this non-stimulating electrode (22) is configured to not apply transcutaneous electric nerve stimulation.During activity stimulated (active stimulation), voltage measurement was used for detecting (a plurality of) stimulating electrode and when no longer is suitable for providing transcutaneous electric nerve stimulation.This may be because the connection of one of other electrodes recovers, and other electrodes become and are suitable for stimulating.Benefit from this possible recovery, preferably also measure the resistance of the electrode that is not stimulated.As long as current electrode is no longer suitable, can from the resistance measurement of having finished, select next electrode.Therefore, during stimulation period, the high voltage measuring method is used in the resistance measurement of stimulating electrode.Because high voltage and typically short boost pulse, the precision of this measuring method is lower, but this measurement is enough to be used in the quick response of anti-fault mechanism.For non-stimulating electrode and for high-acruracy survey more, use the low-voltage measuring method.This intercourse measure all electrodes or in single interruption the measurement electrode subclass, to keep these interruptions restricted in time.If between stimulation period, detect non-stimulating electrode have with (some) stimulating electrodes quite or even lower resistance, this non-stimulating electrode is added to the electrode that can be used for stimulating and concentrates.This point depends on the actual stimulation strategy whether new electrode is used to stimulate.For the present invention, if preferably (a plurality of) primitive stimulus electrode loses them and is connected with the good of skin, this newfound electrode then can be used for taking over to stimulate.
In an embodiment of equipment, equipment is configured to measure at the instantaneous intercourse that applies transcutaneous electric nerve stimulation the resistance of non-stimulating electrode.Because this thorn is goaded into action with the low-voltage measuring method and disturbed mutually, this measurement occurs in the instantaneous interruption in the stimulation.And the pulse of using in low-voltage is measured does not generally longlyer reduce certainty of measurement with the capacitor function of guaranteeing skin than the pulse period of using in high voltage measuring.
In an embodiment of the equipment that comprises a plurality of electrodes, equipment is configured to measure the electrode resistance of a plurality of electrodes to discern new stimulating electrode during recalibrating operator scheme.
In an embodiment of equipment, equipment is configured to measure at first electrode subset electrode resistance of a plurality of electrodes.This first subclass for example can be the original electrode collection that has less resistance value between electrode and skin, thereby can comprise the electrode collection that can recover the electrode of transcutaneous electric nerve stimulation or reduce via it.
In an embodiment of equipment, equipment is configured at the fixed time, and window applies neuroactive stimulus signal to second electrode subset of a plurality of electrodes, monitor the electrode resistance variations in time of second subclass, wherein this equipment special electrodes that is configured to from second subclass to select resistance to be lower than preset limit over time or special electrodes group are as stimulating electrode or a plurality of stimulating electrode.This pre-stimulation between the window phase Neural stimulation electrodes that can be used for more clearly finding at the fixed time.This pre-limited cycles of all avaivable electrodes (5 minutes maximum is just enough, but after 2.5 minutes, the slope that skin resistance improves is clear) that stimulate machine-processed stimulus initially from second subclass.This skin resistance that will cause being had a few descends.Because resistance typically drops between 25% to 1/12, this can cause having the different stimulated point of most low-resistance.Only at this moment, select actual stimulation point based on final resistance measurement.
Alternatively, the history of monitored resistance variation.This provides before the average stimulation and stimulates back resistance and resistance variations speed.When determining new stimulation point, also consider when they are compared with non-stimulating electrode resistance before their stimulation for the electrode that stimulates.If use this second tolerance to find competitive electrode (for example, measuring resistance difference is less than X%, and wherein X is for example 20%), it can be by the limited cycle (2 to 5 minutes) of stimulation, makes that resistance also can be compared after their stimulation.Use resistance variations speed, can calculate stimulating electrode and whether arrive its most low-resistance, perhaps whether its resistance is still reducing.This point is important, because depend on human and environment, the arrival time that most low-resistance spent changed to 15 minutes from 2 minutes.At last, select the electrode of competitive low stimulation resistance (having most low-resistance at the fixed time between window phase changes).This reason is that the stimulation point that has realized that generally has lower resistance than pessimal stimulation point to be improved.The theory of back be good stimulation point have free teleneuron or than pessimal stimulation point more near the nerve of skin, and the stimulation of skin improves its electrical conductivity.Because for good point, there is the less skin histology that can improve its electrical conductivity, the improvement of stimulation is inevitable lower.
Second subclass can be the simplification collection of the available a plurality of electrodes of equipment on the electrode pad for example.Alternatively, second subclass can be from all electrodes in the available a plurality of electrodes of equipment.
In an embodiment of equipment, equipment is configured to regulate the electric current of recalibrating during the operator scheme via the position of regulating electrode or a plurality of electrodes with the resistance that reduces electrode or a plurality of electrodes with the resistance that reduces electrode or a plurality of electrodes and/or via applying electrode or a plurality of electrode again.For example, owing to move, electrode is not so good with being connected of skin or electrode is mobile.Usually, can more easily find stimulation point, because the redness of skin at primitive stimulus point as seen.Only needing to spend some slight effort instructs patient or Therapist electrode to be moved to its home position when receiving instruction receiving signal or slave unit.
Equipment can also be configured to via selecting to have another electrode that reduces resistance from a plurality of electrodes that are used for applying transcutaneous electric nerve stimulation and regulate electric current during recalibrating operator scheme.No matter selection has the different electrodes that reduce resistance is on the position or also regulated the electric current of the skin of flowing through on amplitude.
Equipment can also be configured to via selecting the third electrode subclass from a plurality of electrodes that are used for applying transcutaneous electric nerve stimulation, regulates electric current via the electrode of the third electrode subclass of the resistance that is used to reduce electrode or a plurality of electrodes during recalibrating operator scheme simultaneously.Select a plurality of electrodes can more easily reduce impedance, because the total impedance of two impedances that are arranged in parallel is less than any one independently impedance.And this embodiment can follow topology, thereby improves effect of stimulation.
Equipment can also be configured to via selecting the 4th electrode subset to regulate electric current during recalibrating operator scheme from a plurality of electrodes that are used for applying transcutaneous electric nerve stimulation, depends on that wherein local physiological function, sensing resistor and user interactions select the 4th electrode subset.The user can change the size of the 4th electrode subset that transcutaneous electric nerve stimulation is applied in via the 4th electrode subset.Alternatively, local physiological function determines the effective stimulus (efficient stimulation) of size to guarantee equipment of the 4th electrode subset.
When adjusting position and/or among the embodiment of the equipment when applying electrode or a plurality of electrode again, equipment is configured to be provided for adjusting position and/or apply the instruction of electrode or a plurality of electrodes again to the user.For example, when the measurement of having preserved a lot of electrodes is historical, might be redirected patient or clinical medicine teacher traveling electrode or a plurality of electrode in original low-impedance relatively direction of measuring.Also may expand this, especially when using a plurality of electrod-array by in the measurement that receives, seeking predetermined pattern.Instruction can comprise that picture " further moves down electrode " or the user notification of " inspection contact skin ".
In an embodiment of equipment, when wherein equipment was configured to select to have another electrode that reduces resistance from a plurality of electrodes, these a plurality of arrangement of electrodes were on electrode pad.
A second aspect of the present invention comprises the method for transcutaneous electric nerve stimulation, comprises using the equipment that comprises electrode, and this method may further comprise the steps thus:
The variation of detection of skin impedance, and
When detecting the Skin Resistance of variation from being used for neuroactive stimulation applications pattern
(30) switch to recalibration operator scheme (32).
In an embodiment of the present invention, this method comprises that also the adjacent electrode of interpolation has than Low ESR by adding adjacent electrode and the step of the electrode number that dynamic adjustments is used to stimulate to existing stimulating electrode.The benefit of this embodiment is that it allows to follow topology, thereby improves effect of stimulation.
This method also can comprise the step of dynamically adding adjacent electrode to existing stimulating electrode, and wherein adjacent electrode has the distance distance nearest than the low resistance position.The benefit of this embodiment is that it has improved the ability of the slight shift of handling electrode, and making still stimulates the most low-resistance point.
This method also comprises the known physiological function of the body part that depends on that electrod-array applies and the step of dynamically adding electrode.The benefit of this embodiment is that it can realize larger sized muscle, body of gland or neural even stimulation.
Description of drawings
Above-mentioned and other purposes of the present invention and feature will become from the following detailed description that (it discloses embodiments of the invention) in conjunction with the accompanying drawings considered and manifest more, in the accompanying drawings:
Fig. 1 illustrates the example of known TENS equipment;
Fig. 2 illustrates the example of support/combination of electrodes;
Fig. 3 illustrates portable TENS equipment;
Fig. 4 illustrates projected electrode;
Fig. 5 illustrates the general view according to TENS equipment state of the present invention;
Fig. 6 illustrates the trouble-proof substantially summary with automatic Restoration Mechanism according to TENS equipment of the present invention;
Fig. 7 illustrates the stimulation track with overlapping stimulation time interval;
Fig. 8 illustrates the simulation of using two variablees and the stimulation of only using a variable to estimate;
Fig. 9 is illustrated in overlapping and uses one-period reset the error in the simulation of variable of variable and two periodicity that resets in the cycle;
Figure 10 is depicted as low resistance point that stimulate to select and partly around three medium resistance points of this low resistance point.The light gray point has too high resistance and is unsuitable for stimulating;
Figure 11 is illustrated in the favourable geometric format that has equidistance between the stimulated zone;
Figure 12 illustrates the example with three electrodes, and wherein each electrode applies identical electric current, and different voltage is provided simultaneously.In this example, boost pulse is offset a little in time with simplification and remains in the voltage restriction of equipment, and stimulation synchronously also is feasible;
Figure 13 illustrates measuring resistance differentiation in time, and green line #2 (bottom) stimulates line;
Figure 14 illustrates the stimulation of high resistance electrode.
The specific embodiment
Whether the correct functional electrode that is connected to skin of its use that depends on to a great extent of TENS equipment has the good tram that contacts and whether be applied to skin.
Because the progress in the technology microminiaturization and the progress of battery life, so-called portable TENS equipment occurs on market.These are useful for the user because they not only in static environment as the hospital and also the picture family, work in or when mobile (for example, referring to Fig. 3) provide pain relief in the point variously.Especially for this portable TENS equipment, because the environmental condition that moves and change of health, the contact between electrode and the skin is difficult to keep.
Fig. 3: portable TENS equipment
Typically, use is expressed to the support or the coat of skin with electrode or uses the combination (for example seeing Fig. 2) of the two, uses glue that electrode is remained on appropriate location (for example referring to Fig. 1).The known disadvantage of glue is to use for a long time common chafe; Therefore, researched and developed increasing dryness electrode solution.Second shortcoming is to lose its part bonding strength based on the electrode of glue or gelinite after using limited number of times.
Electrode is put on correct position for not being to be difficult for expert's the equipment user.WO1999052588A1 has described the electrode group (such as matrix) that uses resistance measurement to find correct stimulation point automatically.Can expand this by in the measurement that receives, seeking predetermined pattern, and it comprises that picture " further moves down electrode " or the user notification of " inspection contact skin ".Altogether, these inventions are by selecting correct stimulation point to provide huge benefit for the user.
Improve the another way that contacts between electrode and the skin and be to use projected electrode, WO03/082104A1 sees Fig. 4.
Fig. 4: projected electrode
Above-mentioned mechanism all can not be guaranteed the contact not disturbed sometimes (chance) between electrode and the skin fully.For example, the glue that is used for fixing electrode generally makes electrode to remove easily after using, and this point has limited its adhesion characteristic.Support and coat have trend and their the possibility modification that moves their positions on skin, lose the connection between electrode and the skin.Although projected electrode has improved contact skin, they can not guarantee contact.
Some TENS equipment have the automatic shutdown mechanism of anti-fault, if the contact between electrode and the skin is lost, then stop to stimulate.This has prevented that potentially chance from touching suspension electrode and may cause dangerous or unhappy electric shock to the user.In case device shutdown needs user command to restart stimulation.
Known anti-fault mechanism has significant disadvantages.At first, in dynamic environment, the contact between electrode and the skin possible disconnection and anti-fault mechanism very continually be arrestment continually.In this case, the user is restarting equipment continually, become trouble and make people's unhappiness of this behavior.In addition, if the user forgets or can not restarting equipment, equipment is inhibition of pain no longer.Secondly, known anti-fault mechanism not counter electrode is made a response to the displacement of another location from a position on the skin.In this case, although contact skin is not interrupted, may stimulate the suboptimum position now, this has reduced effective pain relief and even may cause pain.
Embodiment 1: recover automatically from the bad connection between skin and the electrode
The functional of TENS equipment described by state machine.When equipment passed through the electrode activity chafe, it applied high voltage (about 80 to 160 volts 0.3 millisecond) to skin.This is that so-called high voltage stimulates state.
Stimulation mechanism is typically used constant current I.Because the resistance R of the connection between electrode and the skin changes, stimulation mechanism dynamically regulation voltage to keep current constant:
R＝V/I
As anti-fault mechanism, if voltage surpasses scheduled voltage V
Maxstim(because the resistance level I that raises), then equipment stops high voltage stimulating.
Yet the anti-fault mechanism of conventional TENS will enter halted state now, and TENS equipment of the present invention switches to low-voltage and measures state.At this state, do not stimulate not put on skin, but low-voltage current (typically between 1 to 10 volt) puts on electrode subset, electric current I no longer keeps constant simultaneously, but allow its scope 0 to I
MaxstimBetween.Isolating circuit (may be embedded in (reconfigurable) high-power chip) is preferably carried out this operation.
If equipment has a plurality of electrodes, then might be one by one or measure the resistance of these electrodes simultaneously in groups.Especially, it is favourable that measurement simultaneously originally all had high-resistance electrode collection.If measure the high resistance of whole collection, all electrodes are classified as has high resistance.If measure low resistance at this group, the subclass of further measuring in this group can judge which electrode has most low-resistance.
The resistance measurement of electrode is divided into three collection with electrode.
The low resistance collection is to have the V that is enough to be used in stimulating
MaxstimLow resistance and be no more than V
MaxstimThe electrode collection.If should collection no longer be empty, then equipment recovers and forwards high voltage to stimulate state automatically.
The medium resistance collection is the electrode collection with this resistance, and the feasible active thorn of this resistance is goaded into action and caused voltage to surpass V
MaxstimBut resistance is lower than the second cutoff level R
MaxThe electrode that should concentrate is connected to skin, the low inadequately electrode to stimulate this to concentrate of this its resistance of electrode of concentrating.
The high resistance collection is to have to be higher than the second cutoff level R
MaxThe electrode collection of maximum resistance.Suppose that no longer the electrode in this set is connected to skin, thereby be not used in stimulation.
If resistance measurement is divided into the high resistance electrode with all electrodes, then electrode patch can be intactly from skin removed.After the limit cycle of carrying out other measurements, if the every other measurement result of measuring is categorized as the high resistance electrode with all electrodes, then equipment enters halted state.
In halted state, equipment is measuring resistance and not stimulating not.Need user behavior to restart stimulation.
The general view that Fig. 5 provides in single electrode (and ground connection) situation three classifications and equipment how measuring resistance to be reacted.
Anti-fault stimulating system and two kinds of resistance measurement methods with three kinds of states.
SM represents stimulus modelity.If equipment has the resistance level that is lower than threshold value Tl1, then equipment begins to stimulate, and comprises the high voltage measuring of resistance.
RM represents a kind of recalibration pattern of automatic recovery.If device measuring goes out to be higher than the resistance value of threshold value Tl1, but then equipment directly stops to stimulate the low-voltage that begins resistance to measure.
The anti-fault of FS representative.Continue certain one-period if device measuring goes out to be higher than the resistance level of threshold value Tl2, then equipment stops to stimulate and stopping measuring resistance, and will only restart when clear and definite user command.
Fig. 6 illustrates state transition diagram, has summarized the basic anti-fault of using automatic Restoration Mechanism.
NV=no-voltage halted state
The SM=high voltage stimulates state, and
RM=recalibrates pattern and represents low-voltage to measure state
R＞Tl1=resistance is higher than threshold value Tl1,
R＜Tl1=resistance is lower than threshold value Tl1,
For t=D1, R＞Tl2=is for cycle D1, and resistance is higher than Tl2
The UC-stp=user command stops
The UC-strt=user command begins
At first, equipment is in halted state NV, and does not apply any voltage to its electrode.Begin to stimulate order UC-strt if the user provides, as first step, whether equipment use low-voltage measurement electrode can be used for measuring the stimulation among the state RM.If do not detect kind electrode, and find too high resistance, then after overtime D1, device shutdown turns back to halted state NV.On the other hand, (electrode of R＜Tl1), then equipment enters stimulation state SM if find to have enough low resistances.It applies higher voltage to stimulate the user to electrode then.Between this stimulation period, by monitoring the resistance on actual voltage measurement (a plurality of) stimulating electrode.Too high (R＞Tl1), then equipment stops to stimulate, and turns back to measurement state RM if resistance becomes at effective stimulus.
User notification #1: equipment follows the tracks of how long self be in low-voltage measurement state, and this equipment informs that the user is not finding suitable stimulation point after the cycle USERTIMER1 sometime.And when equipment entered halted state (with relative due to the user command) owing to automatic shutdown mechanism, equipment was informed the user with this point.In this case, the user will not need to improve the contact between electrode and the skin.(also referring to the electrode pattern patent documentation).
User notification #2: equipment also may enter the stimulation state contingently and continue a brief time, but it mainly is in the measurement state.In this case, the effective stimulus cycle is short, but last mechanism will not informed the user when reaching USERTIMER.If actual stimulation time sometime at interval USERTIMER2 drop to and be lower than X%, if then the user is apprised of bad contact, this will be favourable.Therefore, equipment is followed the tracks of the last USERTIMER2 time, promptly it be in stimulation period time how long: STIM%.If STIM%＜X% then informs the user.
The direct mode of keeping STIM% is to keep formation in the memorizer (time, stimevent), wherein stimevent starts or stops.In addition, if except the time for＞USERTIMER2 stimulates and continues, STIMTOTAL1 is set to drop on [timenow-USERTIMER2 fully outside the USERTIMER2, timenow] in the summation STIMTOTAL1 of all closed intervals [stimstart, stimend] kept.
For the total stimulation time in the computation interval [timenow-USERTIMER2, timenow], the simple algorithm below using:
STIMTOTAL=STIMTOTAL1 (comprising all closed intervals)
If (t stimend) is incident the earliest in the formation, then STIMTOTAL+=t-(timenow-USERTIMER2).(comprising incident the earliest, the open interval)
If (t stimstart) is up-to-date event (comprising up-to-date event, the open interval) in the formation, STIMTOTAL+=timenow-t then,
STIM% is STIMTOTAL/USERTIMER2 now.
Step below adopting is kept this formation:
If for the last incident in the formation (t, event), t＜time-now-USERTIMER2 sets up, then from formation remove (t, event).
If event=stimstart and formation are not empty, then next event be (t2, stimend), STIMTOTAL1-=(t2-t) (noticing that stimtotal1 only keeps the closed interval)
If event=stimstart and formation are empty now, STIMTOTAL1=USERTIMER2 (continue that USERTIMER2 is outside the time at least except when stimulate, we define STIMTOTAL1 is USERTIMER2) then
If equipment switches to the stimulation state from the measurement state, then to formation add (timenow, stimstart)
If equipment switches to the measurement state from the stimulation state, then to formation add (timenow, stimend)
If in formation, exist last incident (t, stimstart): STIMTOTAL1+=(timenow-t),
Otherwise STIMTOTAL1=0 (formation is empty)
The shortcoming of this direct embodiment is that it is not provided with the border to the size of formation, and this may be problematic for small portable apparatus.In order to simplify the embodiment of preserving STIM%, can change into and preserve the approximate of STIM%.
Obtain the simple approximate of STIM% by preserving two variable stim1 and stim2.
They are defined as follows:
Stim1 comprises stimulation time actual in the interval [timenow, P], and wherein P is defined as follows:
P＝Timenow-Timenow?modulo?2＊USERTIMER2
Stim2 comprises stimulation time actual in the interval [timenow, Q], and wherein Q is defined as follows:
Q＝Timenow-(Timenow+USERTIMER2)modulo2＊USERTIMER2
Effect is shown in Figure 7.Stim1 and Stim2 basic cycle property ground " resetting " have the cycle of two overlappings to 0.Therefore, at any time, how many stimulations take place in the USERTIMER2 time in one of variable accurate tracking at least.
Can drawing USERTIMER in the end from these two variablees, that the good estimation what stimulate took place the cycle is as follows:
Definition stim 1duration=timenow modulo 2*USERTIMER2
Definition stim2duration=(timenow+USERTIMER2) modulo2*USERTIMER2
Evaluation method:
If stim1duration＞stim2duration, then STIM%=stim1/stim1duration;
Otherwise STIM%=stim2/stim2duration.
This method guarantees to stimulate percent always to estimate on length is cycle of length between USERTIMER2 and the 2*USERTIMER2.
This principle can expand to the variable of three or more overlappings, and they will shrink the variation that estimation stimulates the length of interval of percent.
Fig. 8 illustrates the simulation of following the tracks of the effective stimulus time, and uses the estimation of one or two cycle reset stim variable how to be different from calculating based on formation.Figure 11 illustrates with using a variable and compares, and is much smaller with the difference based on the calculating of formation when using two stim variablees.And as can be seen, actual stim% is over-evaluated or underestimated to handoff technique also discontinuously.
Embodiment 2: the stimulation of a plurality of electrodes that physics is adjacent is to reduce resistance variations and in the influence of skin superior displacement.
The electrode that medium resistance is concentrated only is used for stimulating when they are parallel at least one electrode that low resistance concentrates.The resistance of gained combination guarantees to be lower than single electrode, and is as follows:
1/Rcombined＝1/Rlow+ 1/Rmed
Stimulate the benefit of a plurality of electrodes to be, if the resistance variations of selected stimulating electrode (for example, obviously rising); The influence of the combined resistance existence by other electrodes is weakened.Other low resistances or medium resistance point can be used for the additional stimulus point.Advantageously, this supplemantary electrode should be physically near selected stimulating electrode, if electrode moves on skin, then supplemantary electrode can move to than the low resistance point.For example with reference to Figure 10.
Figure 10: (green) low resistance point that selection is used to stimulate and part are around three (dark-grey) medium resistance points of this low resistance point.The light gray point has too high resistance and is not suitable for stimulation.
Figure 11: the favourable geometry that between stimulated zone, has equidistance
The preferred geometries of a plurality of electrodes is the honeycomb textures with offset row.This guarantees that distance between electrodes all equates, the additional stimulus point around the feasible easier selection low resistance point.For example referring to Figure 11.
The objective of the invention is to calculate which zone should be stimulated by activity.
Three kinds of additional stimulus point selection mechanism:
1) adds consecutive points to existing stimulation point with local most low-resistance (so all lower) than all other consecutive points
A. advantage: follow anatomy, thereby improve effect of stimulation.
2) add the auxiliary magnet that has most low-resistance between consecutive points with minimum range and the equidistant consecutive points to most low-resistance point.
A. advantage: improve the ability of the slight shift of handling electrode, still stimulate the most low-resistance point.
3) select stimulation point according to the known physiological function of the body part that applies electrod-array.
A. advantage: this can realize larger sized muscle, body of gland or neural even stimulation.
The number of the additional stimulus point that adds has double influence:
A) it has increased the electric current that puts on health.No more than 50mA can put on human body skin.Therefore, if V=I*R=＞I=V/R does not then add additional consecutive points.
Because the V maximum is 150 volts in our prototype, the estimation of safety is:
I＝150/R
The resistance R of stimulating electrode collection 1...n is defined by following formula:
R＝1/(1/R_1+ 1/R_2+...+1/R_n)
Because I＜50mA, if
SAFESTIM：50mA＞150/(1/(1/R_1+ 1/R_2+...+1/R_n+1_R_(n+1)))
Then, still can add electrode n+1.
For the device with different V_max, formula is changed to:
SAFESTIMv：50mA＞V_max/(1/(1/R_1+ 1/R_2+...+1/R_n+1_R_(n+1)))
Should recognize that it is favourable having the small size electrod-array, because this guarantees to use one or more electrodes always can satisfy the SAFESTIM demand.
B) it changes the zone that receives on the human body that stimulates.
Although maximum current is constrained to 50mA legally, the user of equipment can control to apply how many electric currents to health between 0 to 50mA.It is to produce the effect of " strong and comfortable " that the official that TENS handles is recommended.Levels of current is subjective, and at different objects and difference.
We propose two kinds of mechanism and control how many electric currents and put on skin:
1) conventional mechanism: increase voltage, this so increase is put on the electric current of skin.
2) new mechanism expects that wherein the variation of voltage is converted into the variation of the electrode number that is used for chafe (thereby change of R).
This second mechanism gives the doctor more controls to stimulated zone, and especially it allows minimum stimulated zone, this means that voltage is near its maximum.Therefore, if the user wishes to increase electric current, then can not use first mechanism.
The advantage in pinprick zone is:
A) have more stimulation targetedly: all energy all put on the indication zone and do not consume at the not function tissue.
At muscle directly in the application-specific as the functional electrical stimulation of target, use low voltage and be favourable than large tracts of land, receive identical stimulus intensity to guarantee whole muscle groups.
Our equipment can change the voltage of each electrode, and this is favourable, because its allows on different electrodes distributed current equably.
Embodiment 3: two kinds of measurement patterns of being benefited from the recovery electrode in the stimulation period
In activity stimulated, voltage measurement was used for detecting (a plurality of) stimulating electrode and when no longer is fit to being electrode.This may be because the connection of one of other electrodes recovers, and other electrodes become and are suitable for stimulating.In order to be benefited, preferably also be the electrode measurement resistance that is not stimulated from this possible recovery.
Therefore, in stimulation period, use the high voltage measuring method for the resistance measurement of stimulating electrode.Because high voltage and typical short boost pulse, the precision of this measuring method is low relatively, but this measurement is enough to be used in the fast reaction of anti-fault mechanism.For non-stimulating electrode and for the measurement of degree of precision, use the low-voltage measuring method.Because thorn is goaded into action with the low-voltage measuring method disturb mutually, this measurement occurs in the instantaneous interruption of stimulation.In this interruption, measure all electrodes or in single interruption the measurement electrode subclass, to keep these break periods limited.And the pulse of using in low-voltage is measured is general longer than the pulse period of using in high voltage measuring, does not reduce certainty of measurement with the capacitor function of guaranteeing skin.
If in stimulation, detect non-stimulating electrode have with (some) stimulating electrodes quite or even lower resistance, this non-stimulating electrode is added to the electrode that can be used for stimulating and concentrates.So this point depends on the actual stimulation strategy whether new electrode is used to stimulate.For the present invention, preferably,, (a plurality of) primitive stimulus electrode is connected with the good of skin if losing them, and this newfound electrode then can be used for taking over to stimulate.
Embodiment 4: the resistance variations that compensation is caused by skin irritation
Figure 13 illustrates the group's of 16 electrodes the typical time-evolution of measuring resistance.After initial resistance was measured, the electrode with most low-resistance was stimulated by activity.On 2 to 5 minutes cycle, resistance typically significantly reduces, and has reduced by 50% in this example, but not the resistance of stimulating electrode typically do not reduce piece like this.In this example, non-stimulating electrode even increase its resistance.
Two advantages of this effect are:
1. if electrode is at the skin superior displacement, the big-difference in the resistance makes and rediscovers original stimulation point easily.
2. the electrode number that when resistance descends, can reduce to be used to stimulate (with reference to above), make stimulate more targeted.
Figure 13: measuring resistance differentiation in time, green line #2 (bottom) stimulates line.
Yet this effect also has the shortcoming that must overcome.
Figure 14: high resistance electrode stimulating
Figure 14 illustrates and is not that the most low-resistance electrode is stimulated but stimulation track that the maximum resistance electrode is stimulated.In 5 minutes stimulation, its resistance drops to 1/3, and original maximum resistance electrode is the most low-resistance electrode now.Therefore, if because interim environment has missed initial optimal stimulus point (for example, the interim disconnection of skin and special electrodes pad), after 5 minutes, above-mentioned recalibration mechanism is no longer selected these optimal stimulus points.
In order to compensate this effect, the mechanism that definition is following:
Mechanism 1: the pre-stimulation
1. begin most to stimulate all avaivable electrodes and a lasting limit cycle (5 minutes maximum is just enough, but after 2.5 minutes, the slope that skin resistance improves is also clear).This will cause descending at the skin resistance of being had a few.Because resistance typically drops between 25% to 1/12, this can cause having the different stimulated point of most low-resistance.
2. only at this moment, select actual stimulation point based on final resistance measurement.
Mechanism 2: memorizer
1. preserve it at each electrode and stimulate historical (between two levels) and its resistance measurement scope.This provides stimulates preceding and stimulation back average resistance and resistance variations speed.When determining new stimulation point, also consider when they are compared with non-stimulating electrode resistance before their stimulation for the electrode that stimulates.If use this second tolerance to find competitive electrode (for example, measuring resistance difference is less than X%, and wherein X is for example 20%), can stimulate the limited cycle (2 to 5 minutes), resistance after the feasible stimulation that also can compare them.
2. use resistance variations speed, whether the electrode that can calculate stimulation has arrived its most low-resistance, and perhaps whether its resistance is still reducing.This point is important, because depend on human and environment, the arrival time that most low-resistance spent changed to 15 minutes from 2 minutes.
3. select to have the competitive low electrode that stimulates back resistance of most low-resistance changed factor.This reason is that the stimulation point that has realized that typically has lower resistance than pessimal stimulation point to be improved.For this point, theory behind is, good stimulation point have free teleneuron or than pessimal stimulation point more near the nerve of skin, and the stimulation of skin has improved its electrical conductivity.Because for good point, there is the less skin histology that can improve its electrical conductivity, the improvement of stimulation is inevitable lower.
The embodiment of the invention described herein is intended to explanation and does not have limited significance.Those skilled in the art can make various modifications and not depart from the scope of the present invention that limits as appended claims these embodiment.
Claims (15)
1. equipment (10 that is used for applying transcutaneous electric nerve stimulation via electrode (22), 12,14), this electrode (22) is arranged to be used for the variation of detection of skin impedance and is disposed for switching to recalibration operator scheme (32) from neuroactive stimulation applications pattern (30) when detecting the Skin Resistance of variation.
2. equipment according to claim 1 (10,12,14), this equipment (10 wherein, 12,14) comprise a plurality of electrodes (18), these a plurality of electrodes (18) are disposed for the variation of detection of skin impedance and are disposed for regulating via these a plurality of electrodes (18) electric current of the skin of flowing through.
3. equipment according to claim 1 and 2 (10,12,14), wherein the Skin Resistance of Bian Huaing causes the fault in equipment (10,12, the 14) function.
4. according to claim 1,2 or 3 described equipment (10,12,14), this equipment (10 wherein, 12,14) be disposed for providing transcutaneous electric nerve stimulation simultaneously, wherein this equipment (10 via more than one electrode (22), 12,14) be configured to change the voltage of each electrode (22) that is used to apply transcutaneous electric nerve stimulation
5. equipment according to claim 4 (10,12,14), this equipment (10 wherein, 12,14) be configured in response to the Skin Resistance that changes, the variation that will be used to apply the voltage of transcutaneous electric nerve stimulation converts the variation of electrode (22) number that is used to provide transcutaneous electric nerve stimulation to.
6. according to claim 1,2,3,4 or 5 described equipment (10,12,14), wherein this stimulation applications pattern (30) comprise stimulation voltage and wherein this recalibration operator scheme (32) comprise measuring voltage, this measuring voltage is lower than this stimulation voltage.
7. equipment (10 according to claim 4,12,14), this equipment (10 wherein, 12,14) be configured to apply the required voltage of transcutaneous electric nerve stimulation with the substantial constant electric current and/or come from substantial constant voltage apply the resulting electric current of transcutaneous electric nerve stimulation and/or come the Skin Resistance of change detected via the resistance of measurement electrode (22) via monitoring via monitoring.
8. according to claim 1,2,3,4,5,6 or 7 described equipment (10,12,14), this equipment comprises a plurality of electrodes (18), this equipment (10 wherein, 12,14) be disposed for the variation of detection of skin impedance during stimulation applications pattern (30), be used to apply the resistance of the voltage measurement of transcutaneous electric nerve stimulation via monitoring from the stimulating electrode (22) of these a plurality of electrodes (18), this equipment (10 wherein, 12,14) be configured to detect resistance from the non-stimulating electrode (22) of these a plurality of electrodes (18) via the measuring voltage of measurement electrode (22) resistance, this stimulating electrode (22) is disposed for applying transcutaneous electric nerve stimulation, and this non-stimulating electrode (22) is configured to not apply transcutaneous electric nerve stimulation.
9. equipment according to claim 8 (10,12,14), wherein this equipment (10,12,14) is configured to measure at the instantaneous intercourse that applies transcutaneous electric nerve stimulation the resistance of non-stimulating electrode (22).
10. equipment according to claim 8 (10,12,14), wherein this equipment (10,12,14) is configured to measure at first electrode subset resistance of the electrode (22) of a plurality of electrodes (18).
11. equipment (10 according to claim 8,12,14), this equipment (10 wherein, 12,14) being configured at the fixed time, window applies neuroactive stimulus signal to second electrode subset (22) of a plurality of electrodes (18), monitor electrode (22) resistance variations in time of second subclass, this equipment (10 wherein, 12,14) special electrodes (22) that is configured to from second subclass to select resistance to be lower than preset limit over time or special electrodes (22) group are as stimulating electrode or a plurality of stimulating electrode.
12. according to each described equipment (10,12,14) in the claim 2 to 10, wherein this equipment (10,12,14) is configured to via the electric current during the following method adjusting recalibration operator scheme (32):
-regulate electrode (22) or a plurality of electrode (18) the position reducing the resistance of electrode (22) or a plurality of electrode (18), or
-apply electrode (22) or a plurality of electrode (18) again reducing the resistance of electrode (22) or a plurality of electrode (18), or
-select to have another electrode (22) that reduces resistance from a plurality of electrodes (18) that are used for applying transcutaneous electric nerve stimulation, or
-via the electrode (22) of the third electrode subclass of the resistance that is used to reduce electrode (22) or a plurality of electrode (18), select the third electrode subclass from a plurality of electrodes (18) that are used for applying transcutaneous electric nerve stimulation simultaneously, or
-from being used for applying a plurality of electrodes selection the 4th electrode subset of transcutaneous electric nerve stimulation, local physiological function, sensing resistor and user interactions are depended in the selection of the 4th electrode subset.
13. equipment according to claim 12 (10,12,14), when adjusting position and/or when applying electrode or a plurality of electrode again, wherein this equipment (10,12,14) is configured to be provided for adjusting position and/or apply electrode (22) again or the instruction of a plurality of electrode (18) to the user.
14. the method for a transcutaneous electric nerve stimulation comprises and uses the equipment that comprises electrode, this method may further comprise the steps thus:
The variation of-detection of skin impedance, and
-when detecting the Skin Resistance of variation, switch to recalibration operator scheme (32) from being used for neuroactive stimulation applications pattern (30).
15. method according to claim 14, wherein this method also comprises the step of electrode (22) number that dynamic adjustments in the following manner is used to stimulate:
-adding adjacent electrode (22) to existing stimulating electrode (22), the adjacent electrode of interpolation (22) has than Low ESR, and/or
-add adjacent electrode (22) to existing stimulating electrode (22), wherein adjacent electrode (22) has the distance distance nearest than the low resistance position, and/or
-depend on that the known physiological function of the body part that electrod-array applies adds electrode (22).
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| EP08156380 | 2008-05-16 | ||
| EP08156380.1 | 2008-05-16 | ||
| EP08169228.7 | 2008-11-17 | ||
| EP08169228 | 2008-11-17 | ||
| PCT/IB2009/051996 WO2009138961A1 (en) | 2008-05-16 | 2009-05-14 | A method and system for dynamic recalibration of tens stimulation points to compensate for changing electrode conditions with fail-safe and auto-recovery functionality |
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| CN102046239A true CN102046239A (en) | 2011-05-04 |
| CN102046239B CN102046239B (en) | 2014-08-20 |
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|---|---|---|---|
| CN200980117780.5A Expired - Fee Related CN102046239B (en) | 2008-05-16 | 2009-05-14 | A method and system for dynamic recalibration of tens stimulation points to compensate for changing electrode conditions with fail-safe and auto-recovery functionality |
Country Status (4)
| Country | Link |
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| US (1) | US8620434B2 (en) |
| EP (1) | EP2288408B1 (en) |
| CN (1) | CN102046239B (en) |
| WO (1) | WO2009138961A1 (en) |
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| CN103930161A (en) * | 2011-11-14 | 2014-07-16 | 路易斯·莫恩 | Stimulation apparatus |
| CN108433705A (en) * | 2013-06-13 | 2018-08-24 | 迪彦希斯有限公司 | Method and apparatus for the test of autonomic nerves system sensitive spot |
| CN108778409A (en) * | 2016-02-08 | 2018-11-09 | 哈洛纽罗公司 | Method and system for the offer for improving electro photoluminescence |
| CN109562266A (en) * | 2016-06-03 | 2019-04-02 | 韦斯特伯格控股公司 | It is assisted using the training of stimulator |
| CN109562266B (en) * | 2016-06-03 | 2023-04-18 | 韦斯特伯格控股公司 | Exercise training assistance with stimulator |
| CN109843370A (en) * | 2016-10-26 | 2019-06-04 | 莱雅公司 | Electroporation device and method for controlling electroporation device |
| CN114081475A (en) * | 2017-11-28 | 2022-02-25 | 韦斯特伯格控股公司 | Training auxiliary stimulator and method for providing electrical stimulation |
Also Published As
| Publication number | Publication date |
|---|---|
| US8620434B2 (en) | 2013-12-31 |
| EP2288408B1 (en) | 2013-07-17 |
| EP2288408A1 (en) | 2011-03-02 |
| CN102046239B (en) | 2014-08-20 |
| WO2009138961A1 (en) | 2009-11-19 |
| US20110066209A1 (en) | 2011-03-17 |
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